Abstract: A rapid exchange aspiration catheter includes a distal portion with a round cross-sectional shape, taken transverse to a longitudinal axis of the catheter. A primary lumen through the catheter has a size and a shape, and extends through the catheter at a location that are optimized for aspiration. In particular, the size of the primary lumen is maximized relative to the outer diameter of the catheter by minimizing the thicknesses of interior walls of the catheter. Such optimization maximizes the rate at which fluid flows through the aspiration catheter without compromising the ability of the catheter to withstand negative pressure (i.e., a vacuum). The present invention also includes systems in which the catheter is used in conjunction with a guide catheter and a wire, systems in which the catheter is used in conjunction with an aspiration element, and methods of using the catheter.

Abstract: Provided is a drug delivery composition comprising at least one polymer and at least one active agent; wherein the active agent is present in crystalline form on at least one region of an outer surface of the composition and wherein active agent surface content is adjusted to provide a selected active agent release profile.

Abstract: Provided is a microneedle unit comprising a case having a space accommodating a fluid and a fluid channel through which the fluid is discharged, a microneedle coupled to a lower portion of the case, a base cover disposed at the lower portion of the case, having a hole through which the microneedle passes, and being vertically movable, a guide pin coupled to the base cover and configured to open and close the fluid channel, and an elastic member configured to impart a restoring force such that the base cover is moved upward by an external pressure and then returns downward again. Therefore, the microneedle unit, which is provided to deliver a fluid into the skin with no pain and no scar, can control injection of the fluid using the guide pin, and repeatedly and conveniently control injection of the fluid using the elastic member.

Abstract: A bowel management system includes a waste collection catheter having at least two distinct sections. The first section is patient proximal when disposed in the patient's rectum and has durometer hardness in the range of about 50 A to about 90 A. The second catheter section is connected to the first section and has durometer hardness in the range of about 5 A to about 49 A. A selectively collapsible, substantially spherical retention balloon is attached coaxially and exterior of the first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most end of the first section of the waste collection catheter, the substantially spherical retention balloon having an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient's rectum without being so large as to trigger a defecatory response in the patient.

Abstract: The invention relates to a carrier for injecting a filler product, in particular for microplasty or lipo-reconstruction, comprising a semi-rigid tubular needle (2) having a longitudinal axis with a closed hemispherical distal end and a proximal end (3) for connecting to an injection device, said needle having an inner tubular surface defining an inner transverse cross-section and an outer tubular surface defining an outer transverse cross-section, wherein at least one output side opening (11) is formed in the needle in the vicinity of the distal end. According to the invention, at least one output side opening (11) is defined by a peripheral edge (12) with a rounded connection profile free of any protruding edge, between the inner and outer surfaces of the needle, and the wall of the needle (1) has a thickness, from the proximal end (3) and over a predetermined length of the needle, which is greater than the thickness of the needle which is constant up to the distal end.

Abstract: Device and method for rapid extraction of body tissue from an enclosed body cavity. Hollow entry cannula with optional core element provides entry into body tissue space such as bone marrow. Aspiration cannula is inserted through cannula into body tissue and is manipulated to advance directionally through body cavity. Optional stylet within aspiration cannula aids in advancing aspiration cannula through body tissue and is removed to facilitate extraction of body tissue through the aspiration cannula. Inlet openings near distal tip of aspiration cannula allow tissue aspiration, with negative pressure source at proximal end of aspiration cannula providing controlled negative pressure. Aspiration cannula may be withdrawn and its path adjusted for multiple entries through the same entry point, following different paths through tissue space for subsequent aspiration of more tissue.

Abstract: The present invention is directed to, in one aspect, a medical apparatus having a nasogastric tube with hypopharyngeal suctioning capability. In one embodiment, the medical apparatus has a flexible nasogastric tube for insertion through a patient's nose. The nasogastric tube has a first end defining a first opening, a distal, second end that defines a second opening, and a length sufficient to allow the second opening to be positioned in a patient's stomach. The medical apparatus also has a flexible oropharyngeal tube for insertion through a patient's mouth. The oropharyngeal tube has a first end and a distal, second end that defines a suction intake. The oropharyngeal tube has a length that is less than the length of the nasogastric tube and which allows the suction intake to be positioned in a patient's hypopharynx region. In another embodiment of the invention, the medical apparatus has a laryngeal mask with hypopharyngeal suctioning capability.

Abstract: Described are novel medical delivery devices that can be used to effectively distribute a medical agent to multiple sites within a tissue volume without requiring the device to be repositioned, including for example to distribute the medical agent within the nucleus pulposus tissue of a spinal disc. Also described are medical delivery devices configured to simultaneously remove fluid from the tissue volume into which a medical agent is being delivered, thus avoiding or otherwise decreasing any pressure build-up and facilitating an effective, uniform delivery of the therapeutic agent.

Abstract: A method of coating a microneedle array by applying a coating fluid using a flexible film in a brush-like manner. A method of coating a microneedle array comprising: providing a microneedle array having a substrate and a plurality of microneedles; providing a flexible film; providing a coating solution comprising a carrier fluid and a coating material; applying the coating solution onto a first major surface of the flexible film; performing a transfer step of bringing the first major surface of the flexible film into contact with the microneedles and removing the flexible film from contact with the microneedles; and allowing the carrier fluid to evaporate.

Abstract: A needle assembly has distal and proximal ends. The needle assembly comprises a body element having distal and proximal ends, an attachment means configured to be attached to a medication delivery device, a button element which is movable from a first position to a second position, and a needle configured to move to the distal direction, when the button element is moved from the first position to the second position.

Abstract: An injection device including a syringe connectable to a corkscrew injection needle via an adapter is disclosed. The corkscrew needle includes a proximal end and a distal end and a bore formed through the proximal and distal ends, the corkscrew needle terminating with a sharpened tip at the distal end. The syringe includes a barrel and a chamber formed therein for containing an injectable substance. The barrel includes a proximal end, a distal end, and an outlet at the distal end in fluid communication with the chamber. The distal end of the syringe connects to the proximal end of the adapter. The adapter bore provides fluid communication between the syringe and the corkscrew needle. The proximal end of the corkscrew needle is rotatably coupled to distal end of the adapter which allows rotation of the corkscrew needle without rotating the syringe.

Abstract: Device and method for rapid extraction of body tissue from an enclosed body cavity. Hollow entry cannula with optional core element provides entry into body tissue space such as bone marrow. Aspiration cannula is inserted through cannula into body tissue and is manipulated to advance directionally through body cavity. Optional stylet within aspiration cannula aids in advancing aspiration cannula through body tissue and is removed to facilitate extraction of body tissue through the aspiration cannula. Inlet openings near distal tip of aspiration cannula allow tissue aspiration, with negative pressure source at proximal end of aspiration cannula providing controlled negative pressure. Aspiration cannula may be withdrawn and its path adjusted for multiple entries through the same entry point, following different paths through tissue space for subsequent aspiration of more tissue.

Abstract: The present invention describes compositions comprising tumor cell debris, tumor lysate or tumor antigens and methods of using tumor cell debris, tumor lysate or tumor antigens for stimulating a specific immune response. The compositions may further comprise at least one TLR ligand. The stimulation of the specific immune response may be used to treat tumors, particularly, brain tumors. The treatment method may also reduce the recurrence of a tumor and/or inhibit or slow down the growth of a tumor.

Abstract: A flow regulating implant is provided with one or more grooves for allowing fluid flow. One or more grooves may have a constant or varying cross-section along its length. One or more grooves may have in it biodegradable material, absorbable material, and/or threads or sutures. A resilient band or coating may be placed around the implant or one or more grooves, to act as a pressure regulator. The implant may have a side projection, such as a side pin, for engaging tissue. The implant may comprise two or more parts that are held at a distance from each other to allow fluid flow between the parts.

Abstract: An epidural space locating device is described, comprising a handle with a proximal end and a distal end; a hollow distal chamber attached to the handle distal end and being provided with a distal connector where a spinal needle is received to be introduced in the patient's body, such that there is a fluid connection between the spinal needle and the distal chamber; the device also comprises a plunger running within the distal chamber from a starting position to a final position when there is a pressure loss within the distal chamber due to the spinal needle has reached the epidural space; the plunger is secured before using the device, which emits a warning signal at the time the epidural space has been reached.

Abstract: Described are novel methods for delivering a medical agent to a plurality of locations within a patient tissue volume such as the interior space of a spinal disc, and also for removing material therefrom during medical agent delivery to enhance the delivery. Also described are medical delivery devices such as needle assemblies configured to facilitate the regional delivery of medical agents to patient tissue.

Abstract: Device and method for rapid extraction of body tissue from an enclosed body cavity. Hollow entry cannula with optional core element provides entry into body tissue space such as bone marrow. Aspiration cannula is inserted through cannula into body tissue and is manipulated to advance directionally through body cavity. Optional stylet within aspiration cannula aids in advancing aspiration cannula through body tissue and is removed to facilitate extraction of body tissue through the aspiration cannula. Inlet openings near distal tip of aspiration cannula allow tissue aspiration, with negative pressure source at proximal end of aspiration cannula providing controlled negative pressure. Aspiration cannula may be withdrawn and its path adjusted for multiple entries through the same entry point, following different paths through tissue space for subsequent aspiration of more tissue.

Abstract: A device for delivering a drug into the skin of a subject is provided. The device includes a drug reservoir and a microneedle having a tip, a length, and a tip sharpness. The microneedle is coupled to the reservoir. The device includes a microneedle actuator coupled to the microneedle configured to drive the microneedle into the skin of the subject upon activation. The tip sharpness and the actuator allow the microneedle to pass through an outer layer of the skin upon activation, and the length is limited such that the tip does not extend past a desired depth below the surface of the skin of the subject, wherein the desired depth is located in the papillary dermis or the reticular dermis.

Abstract: An apparatus for delivering a drug to a subject is provided. The apparatus includes a housing, a microneedle coupled to the housing and configured to extend from the housing when activated, an activation control coupled to the housing and an outer shell. The outer shell includes a top wall having an inner surface and a sidewall extending from the top wall, the sidewall having an inner surface. The outer shell includes a first attachment structure configured to attach to the housing. The outer shell covers the activation control when the first attachment structure is attached to the housing. The outer shell includes a second attachment structure configured to attach to the housing. The outer shell covers the activated microneedle when the second attachment structure is attached to the housing.

Abstract: An apparatus for removing body fluids from a body cavity by suction, such as a thorax, gastric or any other human body cavity or a wound, comprises means (9) to increase the pressure difference between a pressure in a drainage lumen (3) and a pressure in the atmosphere when an auxiliary lumen (5) is open. The apparatus enables removal of clots or other plugs of the catheter and drainage tube in an efficient and not patient disturbing way.

Abstract: [Problem to be Solved] To provide an otologic syringe needle for accurately injecting and dispersing a medical agent into an extremely small region such as a middle ear within an eardrum. [Means for Solving Problem] An otologic syringe needle 10 for passing through an eardrum and injecting a medical agent into cartilage within a middle ear, wherein a length of the needle is in the range of 40 to 60 mm, a cutting angle R of a cutting part 12 is in the range of 10 to 16 degrees, and a diameter D of the needle has gauge of not less than 27. The above-mentioned constitution enables accurate injection and dispersion of a medical agent into a desired place of cartilage located in a middle ear within an eardrum. In more detail, since the needle is reduced in diameter and cutting angle compared with conventional needle, the damage of an eardrum generated when the needle is passed through the eardrum can be avoided as much as possible.

Abstract: A silicon breast implant injector for augmentation mammaplasty which includes a hollow tube and a plunger. The hollow tube has a barrel which has one end tapered to form a first arched barrel connecting to an inverse second arched barrel which in turn is connected to an ejection opening formed at the same diameter as the second arched barrel but into a short inflexible length tube. The plunger can push a silicon breast implant s held in the hollow tube through an incision into patient's submammary pocket. Coupled with a smooth connection between the first arched barrel and the second arched barrel, push resistance can be reduced, and thus can smoothly, quickly, easily and safely move the silicon breast implant into the submammary pocket.

Abstract: Methods and compositions for treating post-myocardial infarction damage are herein disclosed. In some embodiments, a carrier with a treatment agent may be fabricated. The carrier can be formulated from a bioerodable, sustained-release substance. The resultant loaded carrier may then be suspended in at least one component of a two-component matrix system for simultaneous delivery to a post-myocardial infarction treatment area.

Abstract: A needle tip assembly includes a needle tip, a needle tip cover structured and arranged to facilitate installation of the needle tip onto at least one of a pen needle, a pre-loaded syringe, and an injection device, and a slot arranged on a sidewall of a body of the needle tip. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

Abstract: An injection needle assembly includes a needle having a needle point to puncture skin, a needle hub including a first member which holds the needle, and a second member in which a discharge part of a syringe is to be fitted, and an elastic member disposed inside the second member to make liquid-tight close contact with the inner surface of the second member, with the elastic member having an insertion hole in which the needle tube is inserted.

Abstract: An injection device that self-administers a painless vaccine injections. The injection device (10) can be secured to the patient's skin via a separable base portion (12) of the housing of the device, which can be separated from the device when removing the housing and syringe assemblies for disposal. The injection device can provide a method for substantial amount of time performing the injection procedure, that is relatively simple and inexpensive to perform and operate, and that provides a relatively high degree of safety for both the medical personnel and for the patient. The injection device is configured for easy handling, and is manually-powered by the use of the hand or fingers of the medical technician. The device can also comprise a plurality of vaccine syringes at the same time with a single device.

Abstract: The present invention is a hollow needle for attachment to a syringe, through which a liquid can be delivered to the stratum granulosum and/or beneath the epidermis, preferably to an area consisting from the stratum granulosum (included) to reticular dermis (included) and more preferably beneath the papillary dermis during a cosmetic procedure, the needle comprising a distal tip and including a lateral aperture adjacent to the distal tip, wherein the liquid exits the needle via the lateral aperture, and wherein the needle is flexible. Apparatus comprising a needle of the invention and a syringe, and a method of use thereof, is also provided.

Abstract: Described are novel methods for delivering a medical agent to a plurality of locations within a patient tissue volume such as the interior space of a spinal disc, and also for removing material therefrom during medical agent delivery to enhance the delivery. Also described are medical delivery devices such as needle assemblies configured to facilitate the regional delivery of medical agents to patient tissue.

Abstract: A method of coating a microneedle array comprising: providing a microneedle array having a substrate and at least one needle; providing a removable masking layer on the microneedle array such that the substrate is at least partially covered by the masking layer and the at least one needle remains at least partially exposed; and applying a coating material to at least a portion of the exposed portion of the microneedle array.

Abstract: An ophthalmic injection system having coaxial cannulae includes a plurality of syringe bodies and a plurality of cannulae, wherein a first non-flexible cannula is configured to accommodate and guide a second cannula that moves inside the first cannula and penetrates into the internal cavity of an eye globe. The first cannula is long enough to penetrate one or more outer layers of the eye globe. A syringe body is connected to the second cannula for accommodation and infusion of a pharmaceutical composition. A plunger is inserted into an annular space of the second syringe body at its distal end for injecting the pharmaceutical composition to the surgical site.

Abstract: The extensible intravenous (“i.v.”) drip line tubing uses a helical accordion support structure on which the i.v. tubing is attached. The helical accordion backbone has some tendency to spring back, but this is not relied upon to extend and return the i.v. tubing it carries. The carrier structure keeps the i.v. tubing from getting tangle or kinked. A centrally located retractable line, which is located within the center of the helical accordion structure, acts as the retracting mechanism, as it tends to allow the accordion structure to be pulled into an extended position, while upon rewinding the central cord, the helical accordion support structure can be pushed toward a collapsed position without the i.v. drip line tubing becoming tanked, kinked, and thereby blocked. As a safety feature, so the i.v. line does not encounter and strain between it and the point of entry of the i.v. line into the patient, is one or more wrist and or armbands to which the i.v. carrier is attached by a short, strong line.

Abstract: Embodiments of the invention generally provide a device and method for minimizing injection pain and preventing needle clogging during injection of a drug formulation into skin. Generally, the invention provides a device comprising a needle having a point to penetrate skin on one end, a hub having a diameter larger than that of the needle attached to the opposite end of the needle and connectable to a housing defining a chamber for receiving a formulation, and a polymer wrap attached to the hub, wherein the polymer wrap is tapered to the needle so as to pass through skin when the point is inserted into the skin, and wherein a space between the needle and the polymer wrap lies in a flow path of the formulation into the skin, such that formulation is injected through the space between the needle and the polymer wrap.

Abstract: The present invention provides infusion devices and methods for subcutaneous delivery of high viscosity fluids. The devices and methods described are innovative subcutaneous infusion systems that allow for the rapid delivery of viscous therapeutic fluids while avoiding adverse side effects and promoting patient comfort. The devices and methods described are also useful for rapid delivery of high volumes of therapeutic fluids.

Abstract: An intravitreal injection system for administering a pharmacological agent formulation to an intravitreal compartment of an eye, comprising (i) an injection member coupled to, or comprising, an internal formulation chamber that is adapted to receive and contain the pharmacological agent formulation therein, (ii) a needle having a first end that is in communication with a formulation chamber and a second injection end, and (iii) a movable platform for positioning the system on the eye, guiding the needle, and limiting the penetration depth of the needle into the eye.

Abstract: A tool for saving the lives of captured fish that are swollen by expanded gases when brought to the surface includes an elongate hollow tube of rigid construction having a sharp cutting edge formed in a distal free end of the tube. A user grasps a proximal end of the tube and punctures a fish at a predetermined location in its body with the sharp cutting edge to allow gases to flow out of the body of the fish until the body returns to a substantially unswollen condition. The fish is conventionally resuscitated prior to release after the gases have been vented. The tube folds into a handle for storage when not in use.

Abstract: A manually-powered injection device that self-administers a painless injection. The injection device provides a method for substantially painless injections of vaccine and other medication into a patient that does not require the use of an anesthetic, that does not require the medical personnel to spend a substantial amount of time performing the injection procedure, that is relatively simple and inexpensive to perform and operate, and that provides a relatively high degree of safety for both the medical personnel and for the patient. The injection needle can have an outside diameter greater than 0.10 mm and less than about 0.38 mm. The vaccine or other medicament can be injected painlessly through the needle and into the patient at a substantially constant volumetric flow rate of about 0.05 ?L/s to about 50 ?L/s, typically over a 3- to 5-minute period of time.

Abstract: Assembly of a needle (1) and a fluid supply device (7b), the needle (1) being provided with needle coupling means (2), the supply device (7b) being provided with a nozzle (9b), the needle coupling means (2) comprising a standardized construction with standardized internal dimensions according to the Luer standard, the needle coupling means (2) further comprising a projection (5), which renders fitting the needle (1) to a supply device with a nozzle (7a) arranged for cooperation with needle coupling means having standardized construction and dimensions according to the Luer standard impossible, the nozzle (7b) of the supply device (9b) being lengthened relative to a standardized nozzle (9a), such that the needle coupling means (2) with projection (5) can still be coupled to the lengthened nozzle (9b). The invention further relates to a needle (1), a syringe (7b), a method for performing an intraneural puncture and a method for preparing an insertion device for intraneural administration.

Abstract: A needle comprising: a base portion; a stem portion extending from the base portion; a tip portion formed on the stem portion; wherein a length of the stem portion is chosen such that the needle can be used for intradermal or subcutaneous drug delivery, and the base portion, the stem portion and the tip portion are integrally formed.

Abstract: A drug injection needle comprises a puncturing needle part that has a puncturing part that is capable of puncturing a body, a drug introducing needle part that is capable of communicating with the inside of the drug container, and a housing that supports the puncturing needle part and the drug introducing needle part in such a way as to allow the liquid drug to flow between the needle parts. The outer diameter of the puncturing part is not more than 0.254 mm. The outer diameter of the drug introducing needle part is larger than at least that of the vicinity of the distal end of the puncturing part of the puncturing needle part, and a cutting edge is formed at the end of the drug introducing needle part for penetrating through an elastic member that is provided to seal the drug injection port of the drug container.

Abstract: A molded article comprising at least one chain of microneedle arrays wherein adjacent arrays in the chain are interconnected by integrally formed runners. Such a molded article may further comprise two or more chains of microneedle arrays, wherein adjacent chains are interconnected to each other by integrally formed runners. Also, methods of making molded articles and positioning them for delivery to a patient.

Abstract: A packaged kit for performing a photodynamic laser myringotomy includes a plurality of ear needles having different shaped absorbent applicators on distal ends of the needles, a vial of a single dose of an otologic formulation of mitomycin-C, a diluent carrier containing sterilized water, and a syringe. The component parts of the kit are used together to reconstitute the contents of the vial with the water in the diluent carrier, and then draw the reconstituted drug into the syringe. A selected one of the plurality of ear needles is then communicated with the syringe. The syringe and needle are then used to inject the reconstituted drug into the absorbent pad at the end of the needle, and the absorbent pad containing the drug is used to apply the drug to the tympanic membrane. The application of the drug to the tympanic membrane prepares the membrane for a myringotomy procedure, and in particular, a photodynamic laser myringotomy.

Abstract: The present invention relates to novel methods of vaccination and vaccine delivery.

Abstract: The present invention relates to a new type of cannula for syringes or injection devices. The cannula according to the present invention comprises a substantially hard portion and a ductile portion axially arranged therewith, where the substantially hard portion comprises a tip which is adapted to penetrate the skin of a patient. The present invention also relates to an injection device comprising such cannula. The present invention further relates to a method for manufacturing a cannula for an injection device, the method comprising the steps of 1): providing a cannula of a hardened material, the cannula comprising a tip portion, and 2): exposing a part of the cannula other than the tip portion to heat in order to form a ductile portion.

Abstract: A method of thermal forming of refractory alloy suture needles is disclosed. Needle blanks made from refractory alloys are used to form surgical needles, which are heated to a temperature above the ductile to brittle transition temperature but below the recrystallization temperature of the refractory alloy. The heated needle blanks are then mechanically formed into a surgical needle.

Abstract: A syringe barrel is provided with a hollow barrel body, a needle fitting arranged extending in an axial direction from a front end of the barrel body, and a finger flange arranged extending in an outward direction from a rear end of the barrel body. The syringe barrel features that a contour of the barrel body is a polygon in a cross-section taken at right angles to a central axis of the barrel body or that the barrel body is provided with at least one planar surface section formed on an outer peripheral wall of the barrel body. A syringe includes the above-described syringe barrel, a plunger slidably inserted in the syringe barrel, and a piston secured on the plunger.

Abstract: An injection including a syringe having a barrel for containing a medicament, a shell for receiving the barrel with a needle projecting therefrom, a drive mechanism for moving a plunger disposed within the barrel, and a manually operative mechanism for moving the plunger in a stepwise manner to eject doses of the medicament from the barrel through the needle.

Abstract: An injection needle (1) particularly adapted for sclerotherapy is disclosed, comprising a cannula (2) with mainly longitudinal development defining a main axis (X), a duct (4) for passage of a sclerosing substance (L) to be injected into a vein (V) being defined inside said cannula. The duct (4) has at the lower end (2a) an inlet (5) for the sclerosing substance (L) and an outlet (6) for the sclerosing substance (L) at the upper end (2b). At lest a constriction (7) is provided inside the duct (4), one or more through holes (8, 9) made in the wall of the cannula (2) being provided upstream the constriction according to the direction of advancement of the sclerosing substance (L) along the duct (4).

Abstract: Medical devices, systems and kits for filling tissue are disclosed. The device has a first configuration wherein the device can pass through a small catheter or needle placed in the tissue to be filled and a second configuration in which the device is expandable to a predetermined or customizable shape. In one application, the device is adapted to be placed into the skin to reduce facial wrinkles or augment facial features such as the lips. Kits and systems include multiple device sizes, filler tubes, and filler media.

Abstract: A spray device including a barrel having a bypass and at least two spaced stoppers defining a first and second chambers and a spray nozzle. Movement of the first stopper drives the second stopper to the bypass and the fluid in the first chamber into the second chamber, mixing the fluid and substance. Continued movement of the first and second stoppers drives the mixture through the spray nozzle. The spray device may include a third stopper having a body in the tubular barrel which is moved toward the spray nozzle. The movement of the third stopper provides space for the mixture and prevents unpressurized fluid from flowing through the spray nozzle. The third stopper includes an axial stalk. The stalk may be deformable or the stalk may be separate from the body and the spray nozzle includes a longitudinal internal passage which provides communication with the spray port.

Abstract: Injection devices are provided, which reduce potential outflow of therapeutic agents from an injection site. Devices are provided having at least a first lumen containing one or more therapeutic agents and a second lumen containing a second material for injection into tissue. Other devices are provided having an inner lumen with an injection needle to inject a therapeutic agent and an outer lumen that provides a vacuum seal between the injection needle and the needle track. Further provided are methods of delivering a therapeutic agent to tissue.